This study aimed to investigate the efficacy and safety of PDR001 in patients with
advanced or metastatic, well-differentiated, non-functional neuroendocrine tumors of
pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated
gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that progressed on prior
treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02955069.
Two groups of adult patients with advanced (unresectable or metastatic) were included in
this study:
- Well-differentiated (G1/2), non-functional, neuroendocrine tumor of GI, pancreatic
or thoracic (lung/thymus) origin who have progressed on prior treatment
- Poorly-differentiated GEP-NEC who have progressed on or after one prior chemotherapy
regimen.
The study was comprised of the following periods: screening, treatment, end of treatment
(EOT), safety follow-up (30-Days, 60-Days, 90-Days, 120-Days, and 150-Days after the last
dose of PDR001) and post-treatment efficacy follow-up. Subjects were treated with PDR001
as an infusion at a flat dose of 400 mg every 4 weeks (Q4W). Subjects were to continue
study treatment beyond disease progression by RECIST 1.1 until disease progression as per
irRECIST, as per BIRC, unacceptable toxicity, start of new antineoplastic therapy,
withdrawal of consent, physician's decision, lost to follow-up, death, or study
termination by the Sponsor.
Lead OrganizationNovartis Pharmaceuticals Corporation